Patients Undergoing Ankle SurgeryNCT01277159

Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

A study testing B. Nerve Block with Dexamethasone (4 mg). IV saline., D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). and E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). in people with Patients Undergoing Ankle Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Patients Undergoing Ankle Surgery
What is being tested?: B. Nerve Block with Dexamethasone (4 mg). IV saline., D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). and E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients of Dr Levine or Dr Roberts.
Scheduled for discharge from HSS after foot or ankle surgery.
A single-injection popliteal fossa nerve block is judged appropriate.
Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
Patients aged 18-75 years.

Who cannot join

Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
Bilateral surgery
Chronic pain (defined as regular use of opioid analgesics for > 3 months).
Chronic use of steroids (defined as regular use of steroids for > 3 months).
Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Conditions: Patients Undergoing Ankle Surgery
Being tested: A. Control Nerve Block. IV Dexamethasone (4 mg)., B. Nerve Block with Dexamethasone (4 mg). IV saline., C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg), D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)., E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
Keywords: Analgesia, Duration, Popliteal Fossa Nerve Block, Dexamethasone, Buprenorphine, Additives, Ankle surgery
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A. Control Nerve Block. IV Dexamethasone (4 mg).Drug
1. Control Nerve Block. IV Dexamethasone (4 mg).
B. Nerve Block with Dexamethasone (4 mg). IV saline.Drug
1. Nerve Block with Dexamethasone (4 mg). IV saline.
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)Drug
1. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).Drug
1. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).Drug
1. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Study groups in NCT01277159
Study group	Role	What they receive
Control Nerve Block. IV Dexamethasone (4 mg).	Experimental	Control Nerve Block. IV Dexamethasone (4 mg). Receives: Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).
Nerve Block with Dexamethasone (4 mg). IV saline.	Experimental	B. Nerve Block with Dexamethasone (4 mg). IV saline. Receives: Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	Experimental	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) Receives: Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (	Experimental	Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). Receives: Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine	Experimental	Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. Receives: Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).

What is being measured

The primary outcome is the main question the study is designed to answer.

Time it Takes for Nerve Block to Wear Off
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Measured: up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Dec 2011

First posted14 Jan 2011 (estimated)
Study startOct 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patients Undergoing Ankle SurgeryStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277159
Sponsor's protocol ID: 2012-042
Status last verified: Apr 2022
First submitted: 13 Jan 2011
Last updated: 14 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Hallux Valgus, Anesthesia
Not yet recruiting
Effects of Ankle Block on Postoperative Analgesia in Diabetic and Non-Diabetic Patients
Diabetes Mellitus, Diabetic Neuropathy
RecruitingObservational study
French Ankle Ligament Surgery Cohort Study
Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture
RecruitingObservational study
Correlation Between Deficits in Knee ROM Recovery and Difficulty in Dorsiflexing the Tibio-tarsal Joint in Patients Undergoing Total Knee Replacement Surgery.
Articulation Disorders

All Patients Undergoing Ankle Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
ClinicalTrials.gov ID: NCT01277159
Acronym / sponsor ID: 2012-042
Conditions: Patients Undergoing Ankle Surgery
Keywords: Analgesia, Duration, Popliteal Fossa Nerve Block, Dexamethasone, Buprenorphine, Additives, Ankle surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Oct 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 14 Jan 2011 (estimated)
Results: Posted 31 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Control Nerve Block. IV Dexamethasone (4 mg).	Experimental	Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).Control Nerve Block. IV Dexamethasone (4 mg).
Nerve Block with Dexamethasone (4 mg). IV saline.	Experimental	Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.B. Nerve Block with Dexamethasone (4 mg). IV saline.
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	Experimental	Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (	Experimental	Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine	Experimental	Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients of Dr Levine or Dr Roberts.
Scheduled for discharge from HSS after foot or ankle surgery.
A single-injection popliteal fossa nerve block is judged appropriate.
Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
Patients aged 18-75 years.

Key exclusion criteria (8 listed)

Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
Bilateral surgery
Chronic pain (defined as regular use of opioid analgesics for > 3 months).
Chronic use of steroids (defined as regular use of steroids for > 3 months).
Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
A. Control Nerve Block. IV Dexamethasone (4 mg).A. Control Nerve Block. IV Dexamethasone (4 mg).	Drug	Control Nerve Block. IV Dexamethasone (4 mg).
B. Nerve Block with Dexamethasone (4 mg). IV saline.B. Nerve Block with Dexamethasone (4 mg). IV saline.	Drug	Nerve Block with Dexamethasone (4 mg). IV saline.
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)	Drug	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).	Drug	Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.	Drug	Nerve Block with Dexamethasone (4 mg) / block Buprenorphine

Primary outcome

Time it Takes for Nerve Block to Wear Off
Time frame: up to 72 hours
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Results and safety

Results posted to the registry on 31 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Nerve Block. IV Dexamethasone (4 mg).	21	17
Nerve Block With Dexamethasone (4 mg). IV Saline.	22	21
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	22	19
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	22	19
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine	21	16

Primary outcome: Time it Takes for Nerve Block to Wear Off

Time frame: up to 72 hours. Mean (Standard Deviation). Unit: hours

Measure	Control Nerve Block. IV Dexamethasone (4 mg). n = 17	Nerve Block With Dexamethasone (4 mg). IV Saline. n = 21	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp n = 19	Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( n = 19	Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine n = 16
Value	30.4 (5.1)	45.1 (5.2)	32.2 (6.1)	45.6 (5.6)	45.6 (5.8)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Nerve Block. IV Dexamethasone (4 mg).	0 of 17 (0%)	0 of 17 (0%)	Not reported
Nerve Block With Dexamethasone (4 mg). IV Saline.	0 of 21 (0%)	0 of 21 (0%)	Not reported
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	0 of 19 (0%)	0 of 19 (0%)	Not reported
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	0 of 19 (0%)	0 of 19 (0%)	Not reported
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Patients Undergoing Ankle Surgery

Recruiting
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Hallux Valgus, Anesthesia
Not yet recruiting
Effects of Ankle Block on Postoperative Analgesia in Diabetic and Non-Diabetic Patients
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RecruitingObservational study
French Ankle Ligament Surgery Cohort Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Urban principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time it Takes for Nerve Block to Wear Off (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01277159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.